Prediction Augmented Screening Initiative

Part of paid clinical trials in Bedford, Massachusetts.

Sponsor
VA Office of Research and Development
Study ID
NCT06538636
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • PCP-Facing Tools — OTHER
    PCP-facing tools will be turned on as a package: a) enhanced LCS clinical reminder including DP+ generated smart message; b) Integrated one-click DP+ full decision tool for automating personalized information about the net benefit of LCS based on patient characteristics; c) the TurboHM tool: automated Health maintenance app for tracking all preventive care, including a dedicated LCS section with personalized information
  • LCS team population management tools — OTHER
    site-specific dashboard and proactive outreach toolkit

Study Details

Lung cancer is responsible for more deaths in the United States than breast, prostate and colon cancer combined and is the number one cancer killer of Veterans. This is because lung cancer is usually diagnosed when the disease has spread, and cure is less likely. Lung cancer screening (LCS) finds cancer at an earlier stage when it is curable, yet only 20% of eligible Veterans have been screened. Uptake is even lower among Black Veterans despite higher lung cancer risk. Using prediction models to identify high-benefit people for whom LCS should be encouraged improves efficiency and reduces disparities. Moreover, it is more patient-centered as shared decision-making conversations can be tailored with personalized information. The US Preventive Services Task Force has called for research to demonstrate that prediction-augmented LCS can be feasibly implemented at the point-of-care. The investigators propose for VA to lead this effort with a large-scale pragmatic clinical trial to show that prediction-augmented LCS is both feasible and improves LCS uptake.

Key Dates

Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Mar 5, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
23,520 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SCREENING

Arms

  • No Intervention: Usual Care
    Usual care
  • Experimental: PCP facing tools
    Suite of PCP facing tools activated
  • Experimental: LCS team population management tools
    site-specific dashboard and proactive outreach toolkit
  • Experimental: PCP facing tools plus LCS population management dashboard
    both interventions activated

Primary Outcome Measure

LDCT receipt in high-benefit Veterans [ Time Frame: From time of intervention activation at the facility to the receipt of LDCT scan up to 169 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
VA Bedford HealthCare System, Bedford, MABedfordMassachusetts01730-1114
Gemmae Fix, PhD
Renda Wiener
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MABostonMassachusetts02130-4817
Renda Wiener, MD
VA Ann Arbor Healthcare System, Ann Arbor, MIAnn ArborMichigan48105-2303
Tanner Caverly, MD
Ralph H. Johnson VA Medical Center, Charleston, SCCharlestonSouth Carolina29401-5703
Qwaneshia Wilson, MS
(843) 789-6710
Sarah A Jackson, BA MA
(843) 789-6700
Nichole T Tanner, MD MS BS (PRINCIPAL_INVESTIGATOR)

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